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AXS-05 for Depression

Phase 4
Recruiting
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
Current major depressive episode of at least 4 weeks in duration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Study Summary

This trial is being conducted to see if a new medication called AXS-05 is effective in preventing the return of depressive symptoms in people with major depressive disorder. The study will compare AXS-05

Who is the study for?
This trial is for individuals currently diagnosed with Major Depressive Disorder (MDD) without psychotic features, experiencing a depressive episode lasting at least 4 weeks. It's not open to those who've been in AXS-05 studies before, used investigational drugs or Auvelity within the last month, or can't follow study procedures.Check my eligibility
What is being tested?
The study tests if AXS-05 is better than Bupropion at preventing relapse of depression in people whose symptoms improved after taking AXS-05. Participants are randomly assigned to either drug and won't know which one they're getting during the trial.See study design
What are the potential side effects?
Potential side effects for both AXS-05 and Bupropion may include nausea, headache, dry mouth, dizziness, insomnia or anxiety. The exact side effects will vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with major depression without experiencing psychosis.
Select...
I have been experiencing a major depressive episode for at least 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from randomization to relapse of depressive symptoms

Side effects data

From 2019 Phase 3 trial • 327 Patients • NCT04019704
29%
All Others, occurring in <5% of Subjects
16%
Dizziness
13%
Nausea
8%
Headache
7%
Somnolence
7%
Diarrhea
6%
Dry mouth
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AXS-05

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AXS-05Experimental Treatment1 Intervention
AXS-05 tablets, taken twice daily
Group II: BupropionActive Control1 Intervention
Bupropion tablets, taken twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-05
2018
Completed Phase 3
~1390

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
27 Previous Clinical Trials
7,536 Total Patients Enrolled
7 Trials studying Depression
2,154 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be a part of this research trial?

"To be eligible for inclusion in this clinical trial, individuals must have a diagnosis of depression and fall within the age range from 18 to 65. The study aims to enroll approximately 316 participants."

Answered by AI

Is the recruitment phase for this medical study currently ongoing?

"Indeed, the data available on clinicaltrials.gov indicates that this study is actively seeking eligible participants. The trial was initially posted on December 27th, 2023 and recently updated on January 16th, 2024. A total of 316 patients will be enrolled across a network of 32 locations."

Answered by AI

What is the current number of participants being recruited for this clinical study?

"Indeed, the details provided on clinicaltrials.gov indicate that this investigation is currently actively seeking individuals to participate. The trial was initially made available for viewing on December 27th, 2023 and its most recent update occurred on January 16th, 2024. To fulfill the study's requirements, a total of 316 participants are being sought from a network of 32 sites."

Answered by AI

Are individuals who are 18 years of age or older eligible to participate in this clinical trial?

"To be eligible for this research study, participants must meet the age criteria of being at least 18 years old but no older than 65 years."

Answered by AI

At how many different sites is this medical study currently being administered?

"Currently, this clinical trial is accepting participants at 32 different research sites. These sites are spread across various locations including Edmond, Atlanta, Lafayette, and several others. To minimize travel obligations for potential participants, it would be advantageous to select the nearest site based on proximity."

Answered by AI

Has the Food and Drug Administration granted approval for the use of AXS-05 in medical practice?

"AXS-05 has been assigned a safety rating of 3 by our team at Power. This designation is based on the fact that the trial being conducted is in Phase 4, indicating that this treatment has already received approval."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've taken every drug for depression and nothing seems to work. I have tried three other drugs and was in another clinical trial three years ago and the only drug that was effective was the trial drug, so I'm hoping this trial might help.
PatientReceived 2+ prior treatments
I have tried numerous antidepressants over my 30 plus yrs of living with depression. I currently added ketamine torches to my daily take if venlafaxine and bupropion and have not experienced any changes. I am desperate to feel normal again before my end of time. It is getting increasingly harder to keep my Faith.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Will any part of the trial be virtual?
PatientReceived no prior treatments
~211 spots leftby Mar 2026